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Validation study for the scheme of reducing the recurrence rate of hepatitis b-related hepatocellular carcinoma in stage I after comprehensive minimally Invasive surgery with traditional Chinese medicine.

Validation study for the scheme of reducing the recurrence rate of hepatitis b-related hepatocellular carcinoma in stage I after comprehensive minimally Invasive surgery with traditional Chinese medicine.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002320
Enrollment
Unknown
Registered
2019-05-06
Start date
2019-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis b-related hepatocellular carcinoma in stage I

Interventions

Sponsors

the First Affiliated Hospital of Henan University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients who meet the diagnostic criteria of hepatitis B-related hepatocellular carcinoma; 2) Clinical stage I of primary hepatocellular carcinoma; 3) Administrated with comprehensive minimally invasive treatment witin 2 months. Images confirmed that there were no active lesions up to CR or measurable active lesions in vivo, which decreased by more than 80% compared with the original lesions (i.e., those with partial residual activity after comprehensive treatment, but could not be treated with minimally invasive treatment because of their special location). Child-Pugh grading A/B of liver function; 4) Aged 18-75 years, gender unlimited; 5) General condition was good, the Karnofsy score, 1 week before admission to the group, reaches 60 points; 6) Patients diagnosed as Zhengxu and Yuzhi syndrome by TCM; 7) Patients signed an informed consent to participate in the experimental study, and can ensure follow-up.

Exclusion criteria

Exclusion criteria: 1) In the past, within 5 years, or with other incurable malignant tumors at the same time; 2) Aminotransferase, AST or ALT, > 5 times normal value and/or total bilirubin significantly increased > 3 times normal value; 3) Patients with severe infection, fever, hemorrhagic tendency, refractory peritoneal effusion and stage III, IV hepatic encephalopathy; 4) Severe heart, lung and kidney diseases, cerebral hemorrhage. Patients with accidental or severe diabetic complications; 5) Pregnant or lactating women; patients with mental disorders; 6) Allergic constitutions or known allergies to the components of the drug; 7) Those who are participating in clinical trials of other drugs or receiving treatment with other traditional Chinese medicines; 8) Researchers believe that other causes are not suitable for clinical trials (e.g., combined with active alcoholic cirrhosis or autoimmune liver disease).

Design outcomes

Primary

MeasureTime frame
Liver tumor markers;electrocardiogram;liver function;kidney function;blood coagulation;stool routine examination;blood routine;HBV-DNA;routine urine test;T cell subset;imaging examination;

Countries

China

Contacts

Public ContactChen Xinju

the First Affiliated Hospital of Henan University of TCM

chenxinju1215@126.com+86 13700867158

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026